Cn
EN
Platform
Introduction
Platform Introduction
The platform’s dedicated Blow-Fill-Seal (BFS) production line is designed for high-value parenteral preparations such as proteins and antibodies with stringent sterility requirements. Centered on a zero-manual-intervention aseptic process, it enables flexible manufacturing.
It supports flexible production of eye drops ranging from 0.1–0.4 mL and inhalants of 2.5–3.0 mL, widely applicable to biological products for ophthalmic indications including dry eye and corneal repair, as well as respiratory conditions such as asthma.
CMC
Development Services
CMC Development Services
Service
Process & Content
Commercial Manufacturing Process
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GMP Drug Substance Manufacturing01 -
Preprocessing and Forming01 -
Aseptic Filling, Sealing and Demolding01 -
Visual Inspection and Leak Testing01
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Automatic Solution Preparation
Modular design enables automatic liquid preparation with CIP/SIP functions. -
Sterility Assurance
Integrated blow molding, filling and sealing completed within 12–14 seconds, greatly reducing manual intervention and contamination risks. -
High-Efficiency Filling
Filling capacity reaches 12,000 units per hour and 12 million units annually.
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Rapid Cooling
Dual cooling plate system rapidly cools products below 25 ℃ to guarantee stable drug quality control. -
In-line Full Inspection
Inspection speed up to 200 units per minute, enabling 100% in-line integrity testing of products.
Platform
Highlights
Equipment Showcase
Advanced Automated Equipment
车间洁净级别C级，配备全自动配液系统 、CIP模块、吹灌封一体机、自动灯检机、真空衰减检漏机、贴标机、枕包机等设备。
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BFS Dispensing and Liquid Preparation Station -
BFS Integrated Machine -
Vacuum Decay Leak Tester and Automatic Visual Inspector -
CIP Module -
Labeler and Pillow Wrapper